Knee Functionality Recovery Indicators in Athletes Submitted to Ligamentoplasty of the Anterior Cruciate Ligament

NCT ID: NCT06050005

Last Updated: 2023-09-22

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-15
• Study Completion Date: 2024-09-15

Brief Summary

Anterior cruciate ligament (ACL) injuries are recurrent, especially in sports. There is still no consensus on the characterization of functional indicators in this clinical condition, as well as their correlation with measuring instruments and clinical functional tests. It is intended to study the changes in functionality of users undergoing this surgery, aiming with functional assessment scales at different times of recovery. This will allow deciding on more adapted recovery strategies, which can meet the musculoskeletal requirements of the user.

Detailed Description

It is proposed to carry by carrying out quasi-experimental, quantitative and analytical studies. The sample will consist of athletes who have started recovering from ACL surgery and who meet the previously established inclusion and exclusion criteria.

The study will use and compare functional tests (Star Excursion Balance Test, Lateral Step Down Test and Weight-Bearing Lunge Test) with measurement instruments: Knee and Osteoarthritis Outcome Score (KOOS), Lyshom Knee Scoring Scale, Lower Extremity Functional Score (LEFS), Return to Sport After Injury Scale (ACL-RSI) and IKDC Subjective Knee Evaluation Form.

The intervention will be performed on individual athletes who have had anterior cruciate ligament injury for the first time or recurrence of this ligament in the same knee or injury in the contralateral knee.

Conditions

Ligament Injury; Ligament Rupture; Ligament Disorders

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Experimental - rehabilitation activity

All participants will be included in this arm.

Group Type: EXPERIMENTAL

Diagnostic test through functional tests and comparison of scales applied to participants in the pre-surgical and post-surgical period.

Intervention Type: DIAGNOSTIC_TEST

The protocol is based on the ligamentization stages, since the bibliography relates the ligamentization process with rehabilitation. These stages are necrosis, revascularization, cellular priorities and collagen formation, and different care is required for each stage. Taking these aspects into account, the authors developed recommendations to establish a protocol divided by the evaluation phases of the present work. Users should only move on to the next phase if they achieve the expected results, or that makes the total duration of each protocol vary from user to user. tests and scales will be evaluated before surgery, after 6 weeks of surgery and at the end of treatment.

Interventions

Diagnostic test through functional tests and comparison of scales applied to participants in the pre-surgical and post-surgical period.

The protocol is based on the ligamentization stages, since the bibliography relates the ligamentization process with rehabilitation. These stages are necrosis, revascularization, cellular priorities and collagen formation, and different care is required for each stage. Taking these aspects into account, the authors developed recommendations to establish a protocol divided by the evaluation phases of the present work. Users should only move on to the next phase if they achieve the expected results, or that makes the total duration of each protocol vary from user to user. tests and scales will be evaluated before surgery, after 6 weeks of surgery and at the end of treatment.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

• Start of physiotherapy in the preoperative context and continuation of recovery up to 2 weeks after surgery; age equal to or greater than 18 years; With or without meniscal injury; Be able to correctly fill in the assessment instruments and complete the Informed Consent Form;

Exclusion Criteria

• Concomitant bilateral injury/history of surgery or contralateral dysfunction; meniscal suture; cartilaginous injury; injury to the internal lateral ligament, external lateral ligament and posterior cruciate ligament; concomitant intra and extra-articular plastic surgery; individuals with recent heart disease, intermittent claudication, neuropathies and cognitive alterations.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Universidade da Coruña

OTHER

Sponsor Role: lead

Responsible Party

Sérgio Miguel Loureiro Nuno

MSc in Physical Therapy and Movement Analysis and PhD student in Health Sciences

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Daniel López López, PhD

Role: STUDY_DIRECTOR

Universidade da Coruña

Locations

Clínica São João de Deus

Lisbon, , Portugal

Site Status: RECRUITING

Countries

Portugal

Central Contacts

Sérgio Loureiro Nuno, MSc

Role: CONTACT

sergio.nuno@udc.es

00351911713133

Daniel López López, PhD

Role: CONTACT

daniel.lopez.lopez@udc.es

Other Identifiers

Universidade da Coruña

Identifier Type: -

Identifier Source: org_study_id